Degradation of polysorbates 20 and 80: studies on thermal autoxidation and hydrolysis.

The purpose of this work was to study the mechanistic pathways of degradation of polysorbates (PS) 20 and PS80 in parenteral formulations. The fate of PS in typical protein formulations was monitored and analyzed by a variety of methods, including (1)H NMR, high-performance liquid chromatography/evaporative light scattering detection, and ultraviolet-visible spectroscopy. Oxidative degradation of PS in neat raw material was studied using thermogravimetric analysis (TGA), differential scanning calorimetry (DSC), and headspace gas chromatography-mass spectrometry.